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Over-the-counter (OTC) drugs are medicines that may be sold directly to a
consumer without a prescription from a health care
professional, as compared to prescription
drugs, which may only be sold to consumers possessing a valid
prescription. In many countries, OTC drugs are selected by a regulatory
agency to ensure that they are ingredients that are safe and
effective when used without a physician's care. It is important to note
that OTC drugs are regulated as ingredients, not final products. By
doing so governments allow manufacturers freedom to formulate
ingredients, or combinations of ingredients, into proprietary
mixtures. [1]

The term over-the-counter may be somewhat
counter-intuitive, since, in many countries, these drugs are often
located on the shelves of stores like any other packaged product.
In contrast, prescription drugs are almost always
literally passed over a counter from the pharmacist to the
customer. Some drugs may be legally classified as over-the-counter
(i.e. no prescription is required), but may only be dispensed by a
pharmacy employee after an assessment of the patient's needs and/or
the provision of patient education. In many countries,
a number of OTC drugs are available in establishments without a pharmacy, such as general
stores, supermarkets, gas stations, etc. Regulations detailing the
establishments where drugs may be sold, who is authorized to
dispense them, and whether a prescription is required vary
considerably from country to country.

Contents

Safety

OTC drugs pose particular drug safety concerns as
they are dispensed and used without the direction of a health care professional. Patients may
combine OTC drugs with their prescription medicine, potentially
causing drug interactions if the substances are
incompatible. Patients may also inadvertently take multiple OTC
drugs containing the same active ingredient, which could lead to an
overdose or increased side-effects.[2] In
other cases, patients may take more than the recommended dose of a
drug, as they may not read or understand the directions or they may
choose to ignore them, believing a higher dose to be more
effective.

While many OTC drugs have wide therapeutic
ranges, some may pose greater risks if not used as directed.
For example, acetaminophen (also known as paracetamol)
is regulated as an OTC drug in many countries and is widely
regarded as safe if used as directed, but it can cause acute liver
failure if recommended doses are exceeded and/or when combined
with alcohol. This problem
is further compounded by the plethora of OTC products containing
acetaminophen, as patients may inadvertently overdose by taking
multiple drugs (e.g. an individual with a common cold may use two
acetaminophen-containing products to treat muscle aches and fever without realizing that they
contain the same active ingredient).[3]

In the United States, the manufacture and sale of OTC substances
is regulated by the FDA.
The Federal Food, Drug,
and Cosmetic Act requires that all "new drugs" are required to
obtain a New Drug Application ("NDA") prior
to entering interstate commerce, but the act exempts any drugs generally
recognized as safe and effective ("GRAS/E") from this
requirement. In order to deal with the vast number of OTC drugs
that were already on the market prior to the requirement that all
drugs obtain an NDA, the FDA created the OTC monograph system to
review classes of drugs and categorize them as GRAS/E after review
by expert panels. This meant that certain classes of OTC drugs were
not required to obtain an NDA and could remain on the market if
they conformed to the monograph guidelines for doses, labeling, and
warnings.

Thus, manufacture must be done either pursuant to an FDA
monograph, which specifies types of OTC drugs, active ingredients
and labeling requirements, or pursuant to a New Drug
Application (NDA), for products which do not fit within a
specific monograph. Because an NDA is extremely expensive to
complete. Examples of OTC substances approveded in the USA are
sunscreens, anti-microbial and anti-fungal products, external and
internal analgesics such as lidocaine and aspirin, psoriasis and eczema topical treatments, anti-dandruff shampoos containing
coal tar, and other
topical products with a therapeutic effect.

The Federal Trade Commission
regulates advertising of OTC products. This is in contrast to
prescription drug advertising, which is regulated by the FDA.

The FDA requires that OTC products are labeled with an approved
Drug Facts label to educate consumers about their
medications. These labels comply to a standard format and are
intended to be easy for typical consumers to understand. Drug Facts
labels include information on the product's active
ingredient(s), indications and purpose, safety warnings,
directions for use, and inactive
ingredients.[4]

Restricted OTC
Substances

An ill-defined third category of substances are those products
having over-the-counter status from the FDA,
while being simultaneously subject to other restrictions on sale.
While these products are legally classified as OTC drugs, they are
typically stored behind the pharmacy counter and are only sold in stores
employing a registered pharmacist; such items may be unavailable in
convenience or grocery stores that stock other non-restricted OTC
medications.

For example, many U.S. drugstores have moved products containing
pseudoephedrine, an OTC product, into
locations where customers must ask a pharmacist for them. A
prescription is not required; the change has been made in an effort
to reduce methamphetamine production. Since the
passage of the Methamphetamine Precursor Control Act, the
purchase of pseudoephedrine in the United States is
restricted. Sellers of pseudoephedrine must obtain and record the
identity of the purchaser and enforce quantity restrictions. Some states may
have more stringent requirements (e.g. Oregon, where a medical
prescription is required to purchase any quantity of pseudoephedrine). Despite these
restrictions, products containing the substance are still
considered OTC in all states except Oregon, since no prescription
is required.

A similar regulation applies to various forms of Emergency Contraception. The FDA considers
these products to be OTC substances for women aged 17 or over, but
prescription
drugs for younger women. [5] To
enforce this restriction and to provide counseling and education on
proper use, an agreement between the manufacturer and the FDA
requires that these drugs are stored behind the pharmacy counter.
Women may obtain the medication without a prescription after
providing proof of age to pharmacy staff and receiving any
necessary patient education.[6]

Furthermore, some Schedule V
controlled substances may be classified as OTC products in certain
states. Such drugs are sold without a prescription, but are subject
to record-keeping rules, quantity and/or age restrictions, and must
be dispensed by a pharmacy.

United
Kingdom

In the United
Kingdom, medication will fall into one of three categories

Prescription Only Medication (POM), which is
usually only available with a valid prescription from a doctor or
via internet suppliers. A pharmacist has to be on the premises for POM
medicines to be dispensed, required by law. The medicine has been
specifically prescribed for the patient holding the prescription,
so it is considered safe for only the recipient to take. Just a
small example of these include Antibiotics, Antidepressants and Antidiabetic
medications. Drugs also included as POM are high strength
painkillers such as Vicodin,
Oxycodone and Codeine (over 15mg); as well as
medications such as Sildenafil (Viagra), Diazepam (Valium) as well as certain topical
skin creams such as Corticosteroids.

Pharmacy Only Medication (P), containing
chemicals, strengths or sizes which require more information,
personal to the person taking the medication. The pharmacist will
determine whether the medicine is safe for the particular customer
based on their responses to a set of questions. Sometimes this is
known as "behind-the-counter" medication. These do not require a
doctors prescription, just a discussion with a pharmacist. Examples
of these include some sleep aid tablets such as Nytol, Human de-worming tablets such as Mebendazole,
painkillers with small amounts of Codeine (up to 15mg), and the emergency
contraceptive pill to patients over 16.

General Sales List (GSL), available off the
shelf with no pharmacy training required to sell (so they can be
sold anywhere, such as supermarkets). Generally considered safe for
most people when taken correctly. Examples of these include
16-packs (or less) of painkillers such as Paracetamol & Nurofen as well as a host of other safe
medications such as small pack sizes of Antiallergy tablets,
Laxative medication and
skin creams.

Medication available only with a prescription is marked
somewhere on the box/container with [POM]. Over-the-counter
medicines are marked with [P]. A prescription is not required for
[P] medicines and pharmacy sales assistants are required by RPSGB
codes to ask certain questions, most of all, whether the patient is
taking other medication, before selling these; in fact many
pharmacies sell [P] medication "no questions asked". It is with
this information that the pharmacist can halt the sale, if need be.
Some medication available in supermarkets and petrol stations is
sold there only in smaller packet sizes. Often, larger packs will
be marked as [P] and available only from a pharmacy. Frequently,
customers buying larger than usual doses of [P] medicines (such as
DXM,
promethazine, codeine or Gee's linctus) will be queried, due to the
possibility of abuse.

Switches between
prescription and OTC

As a general rule, over-the-counter drugs have to be primarily
used to treat a condition that does not require the direct
supervision of a doctor and must be proven to be reasonably safe
and well-tolerated. OTC drugs are usually also required to have
little or no abuse potential, although in some areas drugs such as
codeine are available OTC
(usually in strictly limited formulations or requiring paperwork or
identification to be submitted during purchase). One of the oldest
OTC drugs is aspirin.

Over time, often 3-5 years, drugs that prove themselves safe and
appropriate as prescription medicines, may be switched from
prescription to OTC. An example of this is diphenhydramine
(Benadryl) which once required a prescription but now is available
OTC nearly everywhere. Diphenhydramine is an anti-histamine. More
recent examples are cimetidine and loratadine in the United States, and ibuprofen (Herron Blue/Nurofen) in Australia.

It is somewhat unusual for an OTC drug to be withdrawn from the
market as a result of safety concerns, rather than market forces,
though it does happen occasionally, phenylpropanolamine is one such
example, after it was removed from sale in the United States over
concern regarding strokes in young women.

In the United
Kingdom, it was announced In February 2007, that Boots the Chemist would try over the counter sales of Viagra in
stores in Manchester,
England (previous available
as prescription only). Men aged between 30 and 65 would be eligible
to buy four tablets after a consultation with a pharmacist.[7].

Over-the-counter drugs (OTC) are drugs that do not need a prescription to be bought. When they are properly used, these drugs do not put the health of the patient in danger. Many OTC drug ingredients which were prescription drugs are now considered safe enough for use without a prescription. In many countries, there are special government agencies that regulate OTC drugs, such as the Food and Drug Administration and the Drug Enforcement Administration in the United States. Certain drugs are classified as over-the counter drugs, but may only be given by a pharmacist. This is often the case with emergency contraception medicine. It may also be the case that a small packet of a certain drug is available over the counter, but that larger packets require a prescription.